Biotech
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STEVEN D. SMITH 1070 Calvary Church Road 919-721-0495 / 919-498-1562 Sanford, NC 27332 [email protected] SUMMARY OF QUALIFICATIONS Professional experience and training in the following: * Personnel Supervision / Training / Workplace Safety / Security / Evaluation * Emergency Procedures / Troubleshooting and Problem Resolution / Purchasing * Ordering / Inventory Control / Production Control and Yield Techniques / Paten t * Assistance / Product Development / Inspection / Quality Control and Assurance * Prioritizing Work Flow and Directives * Comply with stringent control of regulatory agencies including OSHA, FDA, EPA * Experience in manufacturing, cGMP and production environments * Skilled in documentation of pharmaceutical and medical records * Proficient in medical, medication, and prescription terminology * Computer competence in both software and hardware applications; skill in data entry, Microsoft Word, Excel, PowerPoint * A distinguished 4+ year military medical career; recipient of eight awards, in cluding the Bronze Star * Recipient of two US Utility Patents EXPERIENCE Pfizer Biotherapeutics, Sanford, NC 2010- 2010 Scientist, Chemistry CTM Manufacturing (Temp Position) Kelly Services * Work as part of a team, with minimal supervision to perform scientific and operational tasks as they relate to process development and clinical production in the Vaccine Development Pilot Plant * Responsible for the implementation, troubleshooting, and reporting of a var iety of processes involved in the production of vaccine product research and c linical lots. * Perform aseptic transfers, sampling, and bench testing with spectrophotomet er, pH meter and microbial gram stains * Prepare and operate the following types of equipment : fixed and portable v essels, ultrafiltration /diafiltration skids, Lyo, depth filter housings, chroma tography column skid, transfer lines, CIP,SIP * Merck Sharp & Dohme Corporation, Morrisville, NC 2007 - 2010 Formerly Diosynth Biotech, a part of Schering-Plough Corporation Senior Bio-process Technician II, Small Scale Purification * Assisted in the development and start-up of commercial manufacturing for clien t companies. * Operated equipment in the process area which included the Columns, Chromaflow Packing Station, LPC Skids, UF Skid, UV meter, Aseptic Sampling, Unicorn Compute r, CIP/SIP System, UV Meter, Integrity test. * Assisted in the training and development of less experienced personnel, acted as shift lead when necessary, provided troubleshooting on equipment and processe s, and provided * Technical input into batch record revisions. STEVEN D. SMITH - [email protected] PAGE TWO Wyeth Biotech, Sanford, NC 2004 - 2007 Bio-process Lead Technician, Chemistry (Pneumo)
* Operated equipment in the assigned manufacturing area which included the UF Sk id, Lyophilization, CIP Skid, SIP Skid, Shell Freezers and sampling. * Delta V computer terminal, responsibilities also included team leader. * Facility start-up, assisting in process validation, review of PNID, process cl inical batches, OJT training, training and utilization of SAP, classroom present ations, proficient in Microsoft Word, Excel and PowerPoint. Bayer Biological Corporation, Clayton, NC 1996 - 2004 Senior Plasma Purification Technician, Dissolving and Filtration * Operated equipment, including the Taylor system, Spectrophotometer, Turbidity meter and heat treatment system; performed Aseptic Sampling, utilization of SAP system, UF Skids, Autoclave, CIP, SIP. * Team trainer; performed coordinator responsibilities when requested. * Assisted in the manufacturing and processing of plasma products. Lederle Laboratories, (Wyeth), Sanford, NC 1994 - 1996 Pharmaceutical Manufacturing Associate Set-up and maintained pharmaceutical equipment; set-up and blend raw materials oral suspension, capsulation. Sampled, tested, and ensured federal and company specifications for manufactur of products. Monitored, maintained, and ensured equipment safety standards. Member of the First Aid Response Team.
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EDUCATION Major: Biology - 2004 State Certified, Bio-Works Bioprocess Course Central Carolina Community College, Sanford, NC - 2004 Completed coursework in Business Administration Central Carolina Community College, Sanford, NC - 2001
* Operated equipment in the assigned manufacturing area which included the UF Sk id, Lyophilization, CIP Skid, SIP Skid, Shell Freezers and sampling. * Delta V computer terminal, responsibilities also included team leader. * Facility start-up, assisting in process validation, review of PNID, process cl inical batches, OJT training, training and utilization of SAP, classroom present ations, proficient in Microsoft Word, Excel and PowerPoint. Bayer Biological Corporation, Clayton, NC 1996 - 2004 Senior Plasma Purification Technician, Dissolving and Filtration * Operated equipment, including the Taylor system, Spectrophotometer, Turbidity meter and heat treatment system; performed Aseptic Sampling, utilization of SAP system, UF Skids, Autoclave, CIP, SIP. * Team trainer; performed coordinator responsibilities when requested. * Assisted in the manufacturing and processing of plasma products. Lederle Laboratories, (Wyeth), Sanford, NC 1994 - 1996 Pharmaceutical Manufacturing Associate Set-up and maintained pharmaceutical equipment; set-up and blend raw materials oral suspension, capsulation. Sampled, tested, and ensured federal and company specifications for manufactur of products. Monitored, maintained, and ensured equipment safety standards. Member of the First Aid Response Team.
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EDUCATION Major: Biology - 2004 State Certified, Bio-Works Bioprocess Course Central Carolina Community College, Sanford, NC - 2004 Completed coursework in Business Administration Central Carolina Community College, Sanford, NC - 2001
